Drug product
Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.
D-1535-2022
Product summary
- Firm
- Direct Rx
- Event
- Event 90869
- Status
- Completed
- Classification
- Class II
- Quantity
- 20 tubes
- Official record key
drug-enforcement:D-1535-2022
Official wording
Reason: CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Code information: Lot: 12JY2216, Exp. 2/29/24
Distribution pattern: Physicians and Medical Facilities in GA and ID
Derived failure modes
-
Manufacturing or process control
CGMP Deviations